Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
V118C · 1 trial · 1 indication
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants legally acceptable representative (LAR) are specifically asked about and record on their electronic vaccine report card (eVRC). Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be reported.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported.
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Percentage of participants with one or more SAEs will be reported.
A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Percentage of participants with MAAEs will be reported.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be recorded.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported.
A SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Percentage of participants with one or more SAEs will be reported.
A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Percentage of participants with MAAEs will be reported.
| Arm | Type | Description |
|---|---|---|
| V118C (Stage 1) | EXPERIMENTAL | Participants will receive a single 0.5 mL intramuscular (IM) injection of V118C administered at 12 to 15 months of age. |
| V118C (Stage 2) | EXPERIMENTAL | Participants will receive a single 0.5 mL IM injection of V118C administered at 2,4,6, and 12 months of age. |
| PCV20 (Stage 1) | ACTIVE_COMPARATOR | Participants will receive a single 0.5 mL IM injection of PCV20 administered at 12 to 15 months of age. |
| PCV20 (Stage 2) | ACTIVE_COMPARATOR | Participants will receive a single 0.5 mL IM injection of PCV20 administered at 2,4,6, and 12 months of age. |
| Name | Type | Description |
|---|---|---|
| V118C (Stage 1) | BIOLOGICAL | IM administration of V118C |
| V118C (Stage 2) | BIOLOGICAL | IM administration of V118C |
| PCV20 (Stage 1) | BIOLOGICAL | IM administration of PCV20 |
| PCV20 (Stage 2) | BIOLOGICAL | IM administration of PCV20 |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: Stage 1: * Is previously vaccinated with 3 routine infant doses of Pneumococcal 20-valent conjugate vaccine (PCV20) * Is 12 through 15 months of age Stage 2: \- Is approximately 2 months of age Both S...
V118C is an investigational monoclonal antibody being developed by Merck & Company, Inc. (MRK) for the prevention of pneumococcal infection. It is currently in Phase 1 clinical development. V118C is also referred to as V118C (Stage 1).
V118C is being studied for pneumococcal infection, an infectious disease caused by Streptococcus pneumoniae. The Phase 1 trial enrolls healthy children as young as 2 months of age in the United States, evaluating V118C in a pediatric population.
V118C is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the Phase 1 clinical study of V118C in children.
V118C is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA. One Phase 1 trial is currently recruiting, and no trials have been completed.
V118C is being evaluated in the Phase 1 trial NCT07300267, titled A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002). The trial is recruiting 210 participants in the United States, is randomized, double blind, and active controlled, and enrolls healthy volunteers.
Yes, V118C (Stage 1) is an alternative name for V118C, the investigational monoclonal antibody developed by Merck & Company, Inc. (MRK) for pneumococcal infection. Both names refer to the same Phase 1 asset.